Op-ed: CHPA, AMA call on Congress to repeal OTC Rx-only FSA provision

WASHINGTON — The Consumer Healthcare Products Association last week teamed up with the American Medical Association in a joint op-ed published in Roll Call that called for the repeal of the over-the-counter prescription requirement for flexible spending accounts.

"OTC medications save time and money for the millions of Americans who rely on them to treat many ailments and injuries," wrote CHPA president and CEO Scott Melville and AMA president Peter Carmel. "These medicines play an important role in our nation’s healthcare system, with almost 90% of physicians recommending patients try to address many ailments with self-care interventions, including the use of OTC medication, before seeking professional care."

In the article, Melville and Carmel point to the Restoring Access to Medication Act, which would repeal the prescription requirement, introduced by Sens. Pat Roberts, R-Kan.; and Ben Nelson, D-Neb.; and Reps. Lynn Jenkins, R-Kan., and Shelley Berkley, D-Nev.

According to an associated cost-savings study, $5.2 billion could be saved by consumers and taxpayers annually if only half of the some 10% of unnecessary visits, as reported by doctors, were avoided.

P&G and Teva’s joint venture, PGT Healthcare, to form new OTC force

CINCINNATI — Procter & Gamble on Thursday announced the creation of a new partnership and joint venture with Teva Pharmaceutical Industries to be named PGT Healthcare.

“This unique and transformational partnership creates one of the broadest and deepest [over-the-counter] product portfolios and geographic footprints in the industry,” Teva president and CEO Shlomo Yanai said. “Each company’s leading brands will experience tremendous growth by combining our strengths. We will be better together.”

The joint venture will be headquartered in Geneva, Switzerland, and will operate in essentially all markets outside of North America. The partnership between P&G and Teva also will develop new brands for the North American market.

PGT Healthcare will focus on best-in-class development and commercialization of branded OTC medicines. The JV will bring together each company’s complementary capabilities and existing over-the-counter medicines. As a result, PGT Healthcare expects to accelerate growth for its parent companies and compete for leadership in the fast-growing, $200 billion consumer healthcare industry. The partnership will start from a solid base of approximately $1.3 billion in annual sales with the potential to grow to $4 billion in annual sales towards the end of the decade.

Under the joint venture, P&G will bring best-in-class consumer understanding, branding, design and in-store merchandising to Teva’s leading brands, such as Ratiopharm — one of Europe’s best-selling generic brands. Teva will bring deeper, broader pharmacy distribution, including its pharmacy sales force and strong pharmacy relationships, broader regulatory capabilities and new technologies to P&G’s leading brands, which include Vicks, Metamucil and Pepto-Bismol.

The joint venture also plans to expand into new OTC categories. Today, P&G has a strong category presence in cough-cold, digestive wellness and women’s diagnostics. Teva’s portfolio includes many technologies and leading brands in other key OTC categories, such as vitamins, minerals and supplements, analgesics, medicated skin, and potential Rx-to-OTC switches.

In connection with the formation of this JV, P&G has sold its OTC plants in Greensboro, N.C. (Vicks production) and Phoenix (Metamucil production) and transferred the employees of both plants to Teva. As part of the partnership, Teva will be the manufacturer and supplier for the PGT Healthcare business and P&G’s North American OTC business.

Pfizer switch of Lipitor under consideration

NEW YORK — It’s official. Pfizer will be exploring a potential switch of its blockbuster lipid-lowering drug Lipitor (atorvastatin calcium).

"There is an intent at some point to try and have an OTC version of Lipitor on the marketplace," Ian Read, Pfizer CEO, president, director and chairman, told analysts on Tuesday. However, for the time being, Pfizer is focused on buttressing Lipitor sales after patent expiry at the end of November through promotion. "Most of the focus is on ensuring the brand has a robust performance in the rest of 2011 and the first 180 days of its loss of exclusivity," Read said. "The brand Lipitor is strong. And these actions we’re taking, they are not specifically directed toward strengthening any potential OTC brand in the future."

Pfizer is assuming both Watson and Ranbaxy will be entering the market with generic versions of Lipitor on the official loss-of-exclusivity date of Nov. 30. And 180 days following Ranbaxy’s entry, Pfizer is preparing for multiple generic pharmaceutical companies to launch a Lipitor equivalent.

"We are continuing to promote Lipitor in order to maximize the vital opportunities, as Ian said, on both pre- and post-LOE," said Olivier Brandicourt, president and general manager of Pfizer Worldwide Primary Care Business. Pfizer launched a $4 co-pay card in December last year, and a new program launched in September — the Lipitor For You program — includes an assisted co-pay for a targeted group of patients. "So we also have partnered to your point, with some customers, so their patients can remain or even begin taking branded Lipitor," he said. "And we are continuing to explore opportunities to partner with the others. So we are definitely supporting the brand again and maximizing the brand pre- and post-LOE."

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